Nalmefene May Reduce Alcohol Consumption Minimally Among People with Dependence
The opioid antagonist nalmefene is approved for treatment of alcohol dependence in several countries, but uncertainty remains concerning its efficacy and safety. Researchers conducted a systematic review and meta-analysis to assess the efficacy and safety of nalmefene for the treatment of alcohol dependence. They identified 5 double-blind randomized controlled trials of nalmefene versus placebo, comprising 2567 participants, and assessed alcohol consumption, health, biological indices, and safety outcomes.
- Compared with placebo, nalmefene was:
- Associated with fewer monthly heavy drinking days* at 6 months (mean difference [MD], -1.65) and 12 months (MD, -1.60), and decreased total alcohol consumption (standardized mean difference [SMD], -0.20 standard deviations) and Alcohol Dependence Scale score (SMD, -0.11) at 6 months. Because the nalmefene group had a much higher study withdrawal rate, sensitivity analyses were done with “best outcome carried forward” for the participants who withdrew. These analyses indicated no difference in alcohol consumption between groups.
- Not associated with any benefit in mortality or health-related quality of life, but was associated with lower liver enzyme levels at 6 months.
- Associated with more adverse events (risk ratio [RR], 1.18 and 1.20 at 6 and 12 months, respectively) and study withdrawal for safety reasons (RR, 3.65 and 7.01 at 6 and 12 months).
* Defined by the authors as days with alcohol intake of ≥ 60 g for men and ≥ 40 g for women.
Comments:
In this meta-analysis, nalmefene’s very modest impact, if any, on alcohol consumption is tempered by concerns about safety. At present, there is not enough evidence to prescribe nalmefene over naltrexone, another opioid antagonist, when considering pharmacotherapy for treatment of alcohol use disorder.
Kevin L. Kraemer, MD, MSc
Reference:
Palpacuer C, Laviolle B, Boussageon R, et al. Risks and benefits of nalmefene in the treatment of adult alcohol dependence: a systematic literature review and meta-analysis of published and unpublished double-blind randomized controlled trials. PLoS Med. 2015;12(12):e1001924.